FDA approves Bayer's Cipro XR (ciprofloxacin extended-release) Dec. 13 for once-daily treatment of uncomplicated urinary tract infections (UTIs), giving the firm nearly one year to establish the extended-release product before Cipro faces patent expiration in December 2003. The indication was supported by an 891-patient study showing the safety and efficacy of 500 mg Cipro XR to be comparable to conventional 250 mg twice-daily Cipro. An application for complicated UTIs was submitted Oct. 29 (Pharmaceutical Approvals Monthly, Dec. 1, 2002, p. 20). Bayer is highlighting the convenience of the once-daily formulatio
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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A new pilot aims to take Brazil closer to ‘digital transformation.’
Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.
The UK’s research-based pharma industry and medical research charities have set out clear action points to drive greater diversity and inclusion in clinical trials.
Blenrep, GSK’s multiple myeloma therapy, faced a major setback when it was withdrawn from the market in 2022. The drug has since made a return as a second-line therapy, and is on track to being reimbursed in England.
